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Jose Luis Gonzalez Larriba
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PC01 - Reinventing Clinical Trials (ID 83)
- Event: WCLC 2019
- Type: Pro-Con Session
- Track: Advocacy
- Presentations: 5
- Now Available
- Moderators:Ivy Elkins, Jose Luis Gonzalez Larriba
- Coordinates: 9/09/2019, 11:00 - 12:30, Seoul (2007)
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PC01.01 - Setting the Stage: Tension Between Patient Safety, Scientific Purity and Patient Inclusion (Now Available) (ID 3555)
11:00 - 12:30 | Presenting Author(s): Jacob Sands
- Abstract
- Presentation
Abstract
Clinical trials are important to the process of better understanding the therapeutic potential of new drugs while also serving as treatment options for individuals seeking the best possible treatment. When writing protocols, we think about how best to determine the effectiveness and side effect profile of the treatment being studied. This can lead to more limited eligibility in an effort to reduce complications not related to the disease or drug. When seeing patients in clinic, we think about how best to treat each individual, which can lead to preferring less strict eligibility. These two perspectives can sometimes seem to be at odds. How do we best define eligibility in a way that both provides scientific rigor while also providing the trial as an option to as many people as possible? This session sets the stage for an in-depth discussion of these 2 important aspects of clinical trials and how to strike the ideal balance for enrollment eligibility criteria.
As part of this introduction, a highlight of the process of drug development through different phases of clinical trials from “pre-clinical work” to phase 3 studies is helpful. The following is a general structure. Any prospective drug must demonstrate compelling results at one phase to then be studied in the next phase. This starts with lab studies and often treatment of mice with prospective drugs. Any studies before treatment of humans is called “pre-clinical.” When results in this setting are promising, treatment in humans starts with phase 1. In this setting the focus of the study is to find the most appropriate dose, and there are often multiple diagnoses allowed for enrollment within that one study. The strategy for dose finding generally includes starting treatment for a few individuals at a low starting dose. After verifying tolerability, another group starts treatment on the study at a higher dose and so on. Less commonly, studies will allow dose increases for each individual that is tolerating the lower dose with ongoing disease control. Dose escalation often continues until finding the “maximum tolerated dose.” Although the side effects of the drug often weigh heavily in determining the dose for further study, responses to the treatment are certainly considered. After determining a dose for future study, this drug may enter a phase 2 study. In this phase, many more individuals are treated at the determined dose, and the effectiveness of the treatment is studied within a specific clinical setting. Results that suggest efficacy often lead to a phase 3 study, which includes randomization to the new drug, or the standard of care treatment, within a specific clinical setting. Although placebo is sometimes utilized, all individuals should get at least the best known therapy. For example, KEYNOTE-189 enrolled individuals with metastatic nonsquamous, non-small cell lung cancer (without sensitizing EGFR or ALK mutations) to the standard of care first line chemotherapy, pemetrexed and a platinum, with randomization to also include either pembrolizumab or placebo. Although people received placebo, it was given along with the chemotherapy, as was pembrolizumab.
This introduction is followed by two related session. One is focused on crafting trials to allow more broad enrollment with the acknowledgment of trials as a treatment option. The other is focused on trial development with full attention toward scientific rigor and study of the drug. A discussion of the balance of these goals follows.
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PC01.02 - Real World Research Groups - ROS1ders (Now Available) (ID 3556)
11:00 - 12:30 | Presenting Author(s): Merel Hennink
- Abstract
- Presentation
Abstract
Presentation Title: Real World Research Groups - ROS1ders
Session: Reinventing Clinical TrialsMerel Hennink
Lung cancer research has made great progress in the last decade. Discovery of more treatable mutations have paved the way to more treatment options. We are moving away from a “one-size-fits-all” chemotherapy towards personalized medicine. (1)
However, these developments require accurate diagnostics to identify the right treatment options. Furthermore, as a common cancer like lung cancer is split into rare subgroups, it also poses additional challenges. Rare mutations in NSCLC (for instance ROS1) result in small patient populations for trials and less bio-materials for research. The main question here is how to navigate this changing landscape.
The ROS1ders – a community
The ROS1 rearrangement was first described in 2007 and occurs in about 1% of patients with NSCLC. Of the estimated 1.5 million new cases of NSCLC worldwide each year, approximately 15,000 may be driven by oncogenic ROS1 fusions.(2) In 2015, little was known about the ROS1 rearrangement and only a single drug was available to treat the disease. Also in 2015, a group of ROS1 positive lung cancer patients formed an international community on social media, The ROS1ders, allowing them to connect with each other. Through social media, patients are becoming increasingly engaged, and discussing the diagnostic and treatment options available in their countries or hospitals. In addition, these national and global online communities, where information is shared, can highlight (inter)national disparities in treatment access.
Treatments
Crizotinib is currently the only FDA- and EMA–approved agent for the treatment of ROS1-rearranged NSCLC. Unfortunately several healthcare systems across the world have difficulty with reimbursing the drug due to lack of data from randomized clinical trials (UK, South Africa, Canada, New Zealand). In Canada, Real World Data from the ROS1 Facebook group helped in the approval process. “The Committee expressed that they were impressed with the patient input of 259 ROS1 positive patients and caregivers from 32 countries who supported the use of crizotinib. Overall, from the perspectives of patients with ROS1-positive NSCLC, they value a chance to extend their life and spend more time with their families by having a treatment that is effective, and improves their symptoms and outcomes.”(3)Global ROS1 initiative – from advocacy to active research
The ROS1ders transitioned from advocacy to active research in the past few years. Reaching out to academic cancer centers, they strove to increase the amount of cancer models available to stimulate ROS1 research. The Global ROS1 Initiative is a partnership connecting researchers, patients, caregivers, and physicians worldwide. Patients who have an upcoming biopsy contact the national study nurse, and can choose to donate extra material to generate a cell line, a patient-derived xenograft (PDX) mouse model, or both. The goal is to create models and data accessible to all researchers. All models and characterization data will be made available as an open access database to researchers and collaborators. The Global ROS1 initiative has already generated four cell lines at the University of Colorado, and three PDX mouse models are in development. Patients are in the driver seat!(4)
Europe
Diagnostics
Testing is essential to select the right treatment. Nevertheless, systematic diagnostic testing for ROS1 in metastatic NSCLC is not yet included in the European Society of Medical Oncology recommendation, but only suggested. (5) In Europe, access to molecular testing and new medicines differs between individual countries, even within the same country. In the Netherlands, a retrospective study in all patients that tested negative for EGFR and KRAS, showed an increase in ROS1 testing between 2013 (10%) and 2017 (61%) (6). Given the demonstrated added value of patient-driven organizations, both for patients and research, we need a more systematic testing for ROS1, in order to offer effective treatment to more ROS1 patients and strengthen our international community.
ROS1 patients as research partners in Europe
The Global ROS1 Initiative requires streamlined protocols to be successful. Currently, European ROS1ders cannot donate tissue for a variety of reasons. Therefore, a pan-European collaboration should be implemented, that centralizes expertise on the small number of potential tissue donations. In this network, tissue processing should be centralized in a single lab, and the resulting data and models could be distributed to collaborating partners. However, the setup of such network is very difficult, in part due to national differences in legislation.
Furthermore, although we are a European Union, patients are not really united, and bringing together the European ROS1ders is not an easy task. We deal with language, boundary and policy issues. Due to European public health systems, all responsibility is given to doctors. Most patients see less benefit in getting informed and organized. Data protection laws and less use of social media make it more difficult to connect patients. Next, the number of non-governmental organizations supporting lung cancer patients is small - in particular in Europe. And finally, fundraising activities are rather uncommon in Europe. Overall these aspects make it harder for patient advocates to make a difference. As such, international networking and solidarity become even more important.
In the Netherlands, www.stichtingmerelswereld.nl was founded to raise awareness and accelerate research. As a result, research on drug resistance has been initiated in cell lines and PDX mouse models. In parallel, drug resistance is also studied in France and Germany. Combining these individual studies might result in a 1+1 equals 3 scenario.
We strive to unite our national voices to influence European policies and use our European voices to connect national studies.
Understanding the role of personalized medicine https://www.lungcancer.org
Jessica J. Lin MD & Alice T. Shaw (2017) “Recent Advances in Targeting ROS1 in Lung Cancer” in Journal of Thoratic Oncology . https://doi.org/10.1016/j.jtho.2017.08.002
Xalkori for ROS1 positive advanced lungcancer. 2019 (4)
https://ros1cancer.com/ros1-patient-driven-research
D. Planchard et al. (2018) “Metastatic non-small cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up.” Annals of Oncology 29 (Supplement 4): iv192–iv237, 2018 doi:10.1093/annonc/mdy275
Kuijpers Chantal C.H.J. et al (2018). “National variation in molecular diagnostics in metastatic lung cancer. “ Nederlands Tijdschrift voor Geneeskunde 162:D1607
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PC01.03 - Real World Research Groups - ALK+ Group (Now Available) (ID 3557)
11:00 - 12:30 | Presenting Author(s): Linnea Olson
- Abstract
- Presentation
Abstract
There is a natural tension inherent to clinical trials—between scientific rigor and a participant’s hope that an experimental therapy shall prove effective. However, it is important to never lose track of the reason for clinical trials. To quote Dr. Richard Pazdur, Director of the FDA’s Oncology Center of Excellence, ‘We have to understand that the clinical trials are here to serve the patients. The patients are not here to serve the clinical trials.’ (1)
The decision to enroll in a clinical trial—particularly phase I where both maximum tolerable dose and the safety profile are being ascertained—is not a casual one. Generally the prospective participant has exhausted traditional therapies. With the emergence of actionable mutations and targeted therapies, the paradigm for participation is evolving. It is foreseeable that a participant can have a response to a therapy measured not only in months but in years. And when progression does occur, that same participant may enroll in yet another clinical trial.
For many patients with advanced lung cancer, clinical trials now offer the best option for therapeutic treatment.
It is critically important to find the balance between advancing medical research and extending individual lives.
To this end, exclusion criteria need to be reevaluated. A patient who is desperately ill is often willing to tolerate a far higher degree of risk. Arguments for exclusion criteria fail to take into account the fact that this is a representative population; should the drug receive FDA approval, this will be the consumer profile. (2,3)
It is also vital to understand the burden that clinical trial participants take on. First, financial. There is an overriding misperception that participation in a clinical trial is cost free. In reality, it is often only the experimental therapeutic that is provided free of charge.
Clinical trials are procedure rich—from pharmacokinetics to additional scans/MRIs/EKGs/biopsies. In most cases a participant’s insurance is billed for these procedures, resulting in quickly maxed out deductibles and added copays. More frequent visits to the site of the trial require additional time and travel on the part of the participant. Transportation, lodging and meals are often the responsibility of the patient. There are lost wages, for either the patient or their caregiver or both. Often there is also the burden of childcare.
The financial toll adds to the high degree of stress that a patient and their families are already living under. It also means that clinical trials are an option only for those with both the financial means and a solid support system in place. As economically distressed families are unevenly distributed among minorities, the clinical trial population is not representative. Not only does this mean there is an inherent disparity in access to clinical trials, it also impacts the science, as clinical trial participants in an ethically diverse country such as the US are overwhelmingly caucasian. In addition, it is important to point out that healthy volunteers to clinical trials are almost always compensated for both their time and even small things that are typically not covered in a clinical trial for oncology patients—such as parking. (4,5,)
And then there is the physical toll upon a patient. Excessive scanning, multiple biopsies, exhaustion associated with additional visits to the site.
“When you begin to look at a trial from the patient’s perspective and consider the complexity of the trial and what we are asking them to do, is it any wonder that so many patients are refusing to participate? And is it any wonder why so many patients choose to withdraw from a clinical trial?” (6)As accrual is an ongoing issue in clinical trials, it is imperative for both the sake of patients as well as medical science, that the voice of the patient be heard. Patient reported outcomes (7) often fail to capture the actual experience of a trial participant. Rather than being the one size fits all that is commonly handed to participants at each visit now, why not write the PRO with the assistance of actual participants? Humans, unlike their rodent counterparts in the lab, are sentient beings. Potentially a wealth of anecdotal information is being lost simply because no one thinks to ask.
Clinical trials cannot happen without the cooperation of human participants. That cooperation is referred to as compliance. A patient who is noncompliant risks ejection from a trial. This creates a relationship that is inherently unbalanced.
It is possible to address both accrual and the needs of the participant if clinical trials become truly patient centric. To do so one must consider the burden of participation. A clinical trial should be viewed as an opportunity, albeit one that is not risk free. Lessening the burden and removing some of the barriers to participation will better address the needs of both patients and the field of medical research.
1. NCCS Celebrates “Focus on the Care” Reception in Honor of Dr. Richard Pazdur and Ellen Goodman Oct 22 2015 https://www.canceradvocacy.org/news/nccs-celebrates-focus-on-the-care-reception-in-honor-of-dr-richard-pazdur-and-ellen-goodman/
2. Clinical Trial Patient Inclusion and Exclusion Criteria Need an Overhaul, Say Experts
April 23, 2018 Redfearn, S https://www.centerwatch.com/cwweekly/2018/04/23/clinical-trial-patient-inclusion-and-exclusion-criteria-need-an-overhaul-say-experts/3. You Can’t Sit With Us for This Study: Exclusion Factors in Clinical Trials Feb 4, 2019 Krebill, C, NU SCI https://nuscimag.com/you-cant-sit-with-us-for-this-study-exclusion-factors-in-clinical-trials-44a8f6efbd8
4. Clinical Trials and Their Financial Barriers: Increasing Participation, Lowering Financial Toxicity Jan 07, 2019 Rolleri,C, ASCO Communications https://connection.asco.org/magazine/features/clinical-trials-and-their-financial-barriers-increasing-participation-lowering
5. Payment for participation in clinical research: Review of proposals submitted to the ethics committees Perspect Clin Res. Apr-Jun, 2018 9(2): 64–69. Marathe, PA; Tripathi, RK; Shetty, YC; Kuyare, SS; Kamat, SK; That, UM; atte2https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5950612/
6. Merck Changes The Paradigm On Clinical Trials May 11, 2016 Miseta, E Clinical Leader https://www.clinicalleader.com/doc/merck-changes-the-paradigm-on-clinical-trials-0001
7. Patient involvement in clinical research: why, when and how Apr 27, 2016 Sacristán, JA; Aguarón, A; Avendaño-Solá, C; Garrido, P; Carrión, J; Carrión, A; Kroes, R; Flores, A; NCBI PMC https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4854260/
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PC01.04 - Lung Cancer Patients Should Have Better Access to Clinical Research: Relax the Eligibility Criteria (Now Available) (ID 3558)
11:00 - 12:30 | Presenting Author(s): Janet Freeman-Daily
- Abstract
- Presentation
Abstract
Clinical trials are essential for improving treatment of cancer patients. However, only 2%-3% of adult cancer patients participate in clinical trials, and many trials close because they do not enroll enough patients. Others are slow to accrue patients, which prolongs the time required to obtain results. Those trials that meet accrual goals often have cohorts that don’t reflect the demographics or performance status of the real-world population of patients who have the disease.
Why do trials have trouble enrolling enough patients? Some of the significant barriers to clinical trial participation stem from over-restrictive trial eligibility criteria. Unger et al (2019) found 21.5% of patients did not enroll in a clinical trial because they were not eligible. A Kaiser Permanente study of non-small cell lung cancer patients found 80% of the patients were not eligible for two NSCLC treatment studies.
Trial eligibility must balance opposing factors. It must be narrow enough to ensure the effect of the treatment can be determined, yet broad enough that the population of patients is meaningful. Researchers often use “common” eligibility criteria without giving due consideration to how those criteria may impact trial recruitment and the real-world applicability of their study. A population of younger patients with no health issues other than lung cancer might make it easier to identify the effect of the experimental treatment, but this population gives no real insight into how the treatment affects the typical population of lung cancer patients (which has an average age of 71).
Recommendations to modernize eligibility criteria have been recently published by a joint effort of the American Society for Clinical Oncology and Friends of Cancer Research, as well as the US Food and Drug Administration and the National Cancer Institute. The recommendations include relaxing restrictions on brain metastases, minimum age, HIV/AIDS, organ dysfunction, and prior and concurrent malignancies while ensuring patient safety.
Other aspects of a trial may cause patients to decide not to enroll even if they meet the eligibility requirements. Locations of trial sites might require the patient to travel, yet the patient might not be able to afford time or cost of travel, or their insurance might not cover treatment at any trial site. The trial protocol may prohibit certain previous treatments, or require weeks of washout from previous tyrosine kinase inhibitor (TKI) treatments (which raises the possibility of TKI flare).
Preliminary evidence shows that relaxing trial eligibility requirements could result in a greater number of patients becoming eligible for clinical trials. Harvey et al (2019) conducted a retrospective study of 10,500 CancerLinq records of patients with lung adenocarcinoma. They found 47.7% of patients were excluded from clinical trials by traditional exclusion criteria (no brain metastases, no other malignancies, and creatinine clearance greater than 60 mL/minute), while only 1.5% of patients were excluded by the ASCO-Friends recommended expanded criteria that removed these restrictions.
Relaxing clinical trial eligibility while maintaining safety is in the best interest of the patient. Patients are not for clinical trials. Clinical trials are for the patient.
References:
Gore, L, et al. (2017). "Modernizing Clinical Trial Eligibility: Recommendations of the American Society of Clinical Oncology–Friends of Cancer Research Minimum Age Working Group." Journal of Clinical Oncology 35(33): 3781-3787
Harvey RD, et al. (June 2019). “Impact of broadening clinical trial eligibility criteria for advanced non-small cell lung cancer patients: Real-world analysis.” Presentation at ASCO Annual Meeting 2019, Chicago, IL. https://meetinglibrary.asco.org/record/178360/abstract
Jin, S, et al. (2017). "Re-Evaluating Eligibility Criteria for Oncology Clinical Trials: Analysis of Investigational New Drug Applications in 2015." Journal of Clinical Oncology 35(33): 3745-3752.
Lichtman, SM, et al. (2017). "Modernizing Clinical Trial Eligibility Criteria: Recommendations of the American Society of Clinical Oncology–Friends of Cancer Research Organ Dysfunction, Prior or Concurrent Malignancy, and Comorbidities Working Group." Journal of Clinical Oncology 35(33): 3753-3759.
Lin, NU, et al. (2017). "Modernizing Clinical Trial Eligibility Criteria: Recommendations of the American Society of Clinical Oncology–Friends of Cancer Research Brain Metastases Working Group." Journal of Clinical Oncology 35(33): 3760-3773.
Sharpless NE, Doroshow JH. “Modernizing Clinical Trials for Patients With Cancer.” JAMA. Published online January 23, 2019. 321(5):447–448. doi:10.1001/jama.2018.18938
Uldrick, TS, et al. (2017). "Modernizing Clinical Trial Eligibility Criteria: Recommendations of the American Society of Clinical Oncology–Friends of Cancer Research HIV Working Group." Journal of Clinical Oncology 35(33): 3774-3780.
Unger JM, Hershman DL, Fleury ME, Vaidya R. “Association of Patient Comorbid Conditions With Cancer Clinical Trial Participation.” JAMA Oncol. Published online January 10, 2019 5(3):326–333. Doi:10.1001/jamaoncol.2018.5953
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PC01.05 - Representation of Minorities and Women in Oncology Clinical Trials (Now Available) (ID 4059)
11:00 - 12:30 | Presenting Author(s): Narjust Duma
- Abstract
- Presentation
Abstract not provided
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Author of
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EP1.03 - Biology (ID 193)
- Event: WCLC 2019
- Type: E-Poster Viewing in the Exhibit Hall
- Track: Biology
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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EP1.03-21 - Circulating Tumor Cells Isolation Is Not a Useful Prognostic Tool for Non-Small Cell Lung Cancer Patients Candidates to Surgical Treatment (ID 1271)
08:00 - 18:00 | Author(s): Jose Luis Gonzalez Larriba
- Abstract
Background
It is well known that prognostic stratification according to TNM classification of non-small cell lung cancer (NSCLC) patients is somehow imprecise as there exist notable differences among patients endorsed in the same staging. Because of this it is mandatory to find complementary tools to reach a more accurate classification in order to the best selection of treatments for every patient. The presence of circulating tumor cells (CTC) in periferic blood samples has showed worse prognosis in other primary tumors. The aim of this study is analyzing the impact of CTC on disease free survival (DFS) and overall survival (OS).
Method
Periferic blood samples from 28 patients diagnosed with NSCLC in early stages candidates for surgical treatment were obtained. Study period was from June 2011 to October 2013. Blood samples were obtained at least at three different moments: before surgery (S1), one year after the operation (S2) and the last one 2 years after the operation (S3). Blood samples were analyzed by CellSearch method.
Probability of survival was calculated following the Kaplan-Meier method; differences in survival were examined by the Long-Rank test.
Result
Median OS was 34 months and DFS was 11 months. There was no statistically significant differences among patients with or without CTC in S1, S2 and/or S3. When CTC were present, no relationship was observed between the variations in the number of CTCs among the different blood samples and the OS and DFS.
Conclusion
In our study, the presence of CTCs in any of the blood samples obtained during the follow-up showed no relationship with OS and DFS. The same results were observed in relation to variations of CTCs' count.
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MA02 - Miscellaneous Topics in the Management of Early Stage Lung Cancer (ID 116)
- Event: WCLC 2019
- Type: Mini Oral Session
- Track: Treatment of Early Stage/Localized Disease
- Presentations: 1
- Now Available
- Moderators:Mireia Serra-Mitjans, Thomas A. D'Amico
- Coordinates: 9/08/2019, 10:30 - 12:00, Interlaken (1988)
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MA02.01 - Reccurrence Pattern After Adjuvant Customized Chemotherapy Based on BRCA Expression Level (SCAT Trial) (Now Available) (ID 2760)
10:30 - 12:00 | Author(s): Jose Luis Gonzalez Larriba
- Abstract
- Presentation
Background
•Postop platinum-based CT improves outcomes in completely resected NSCLC with nodal involvement, (St II-IIIA). Customization is feasible in adjuvant setting (tissue availability) . Analysis of expressionin genes involved in DNA repair could be use to select CT regiment. •BRCA1 plays an important role in DNA repair pathways and functions as a differential regulator of response to cisplatin and antimicrotubuleagents. SCAT trial results found that for low BRCA1 levels subgroup Cis-Gemcitabine was superior to Cis-Docetaxel and in high BRCA1 levels subgroup Docetaxel single agent without platinum achieved similar survival to Cis-Doc. Analysis of recurrence pattern in different subgroups of the trials has been performed
Method
From Jun/2007 to May/2013 591 patients were screened and 500 p were included (108 in Control arm treated with Cisplatin-Docetaxel and 392 in Experimental arm treated with Cisplatin-Gemcitabine, Cisplatin-Docetaxel or Docetaxel alone according terciles BRCA1 expression level). With a cut-off September 30th 2018 and a median follow-up of 60 months, recurrence pattern are analysed in each arm and subgroup treatment and comparison are made for incidence of risk of recurrence, single/multiple recurrence, thoracic/extrathoracic and site of metastases (liver, bone, brain)
Result
Cumulative recurrence 232/456 evaluable patients (p) (50.8%). Recurrence were seen in 182/354 patients treated in experimental arm and in 50/102 p treated in the control arm (RR 1.04; 0.83-1.30) (p=0.672). Majority of recurrences 159/232 (68.5%) were single site recurrence. Intrathoracic recurrences in 121/232 (52%) while extrathoracic metastatic disease 111/232 (47.8%). No significant differences were seen for single/multiple, intra/extrathoracic recurrences between experimental and control arm. More frequent distant metastatic sites were: bone (42 p), brain (38 p) and liver (11 p) In the experimental group between different treatments no significant differences were found for the overall metastatic rate or for the single/multiple, intrathoracic/extrathoracic recurrences. For specific metastatic sites related to experimental treatment a significant reduction of risk of brain metastases were found in the experimental group with high level BRCA1 treated with Docetaxel single agent (p=0.0016)
Conclusion
For NSCLC resected patients with lymph node involvement (Stages II-IIIA) risk of recurrence remains high with cumulative rate > 50%. There were no differences in the Relative Risk (1.04) of recurrence when control and experimental arm are compared. Majority of recurrences were single site (68.5%) and intrathoracic (52%) but distant metastases developed in 47.8% os p. More frequent metastatic site was bone, followed by brain and liver. Brain metastases risk were significant lower for patients with low BRCA1 expression treated with single agent Docetaxel
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MA22 - Partnering with Patients to Understand Stigma, Disparities and Values Leading to Improved Lung Cancer Care (ID 154)
- Event: WCLC 2019
- Type: Mini Oral Session
- Track: Advocacy
- Presentations: 1
- Now Available
- Moderators:Diego Villalón, Christina Sit
- Coordinates: 9/09/2019, 15:45 - 17:15, Amsterdam (2011)
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MA22.05 - Assessment of Gender Differences in the Psychosocial and Economic Impact on Patients with Stage IV Non-Small Cell Lung Cancer (Now Available) (ID 718)
15:45 - 17:15 | Author(s): Jose Luis Gonzalez Larriba
- Abstract
- Presentation
Background
Incidence of lung cancer in women is rising overtime reporting evident gender-based differences in epidemiology, biology, and treatment outcome. However, little is known about gender-differences regarding psychological, economic and social aspects. The objectives of this prospective study are to evaluate the psychosocial and economic impact of metastatic non-small cell lung cancer (NSCLC), according to gender. Additionally, to assess the emotional burden and the economic impact of the disease on the primary caregiver from a gender perspective
Method
Multicenter, prospective, observational, study of two cohorts of patients with metastatic NSCLC (male and female) in Oncology departments of 20 Spanish hospitals. The following measurement tools were used: the APGAR questionnaire (family functionality: adaptability, partnership, growth, affection, and resolve), the Relationship impact scale, the DUKE-UNC scale (perceived socio-affective support), the patient and the caregiver economic impact scale and the Zarit scale (caregiver burden). All questionnaires were performed at the first visit, repeated 4 months later and following the first and second disease progression.
Result
Of the 333 pts included, 104 were females and 229 male, of whom 63% and 97%, respectively, were smokers/ex-smokers (p=0.0001). More women than men (85% vs 70%) had adenocarcinomas . The median overall survival was longer in women but did not reach statistical significance [17.1 vs 11.0 months, HR 0.732 (95% CI 0.534 to 1.005), p=0.0524]. Most families considered themselves functional (high score in APGAR questionnaire) with no changes in their partner relationship and social support was evaluated as optimal for majority of patients. Around a quarter of interviewed patients said their economic situation was a little worse after the lung cancer diagnosis, without remarkable differences by gender. Statistically significant differences were found between both groups regarding the caregiver´s relationship to the patient (more parents were the caregiver in females than in males) (p <0.0001) and the caregiver’s employment situation (more employed caregivers in females) (p<0.0001). Most caregivers of both sexes considered that taking care of their relative did not pose a significant burden. No remarkable differences by gender were found between the different variables across the study.
Conclusion
This study provides a preliminary insight into gender-related characteristics in the management of advanced NSCLC and its impact on the emotional, social and economic burden of patients and their caregivers, and recall the high priority of researching in cancer from a gender perspective
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P1.03 - Biology (ID 161)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Biology
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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P1.03-45 - Circulating Tumor Cells' Clearance in Blood Samples After Chemotherapy: A Good Prognostic Factor for OS in Advanced NSCLC (ID 1277)
09:45 - 18:00 | Author(s): Jose Luis Gonzalez Larriba
- Abstract
Background
The poor prognosis of patients diagnosed with non-small cell lung cancer (NSCLC) patients in advanced stages requires a close monitoring of treatment´s response in order to plan early changes when necessary. The presence of circulating tumor cells (CTC) in periferic blood samples has showed worse prognosis in different tumors.
The aim of the study is analyzing the relationship between the presence of CTCs in periferic blood samples and overall survival (OS) and progression-free interval (PFS) in advanced stages of NSCLC patients.
Method
Periferic blood samples were obtained from 25 patients diagnosed with NSCLC in advanced stages from April of 2010 to January of 2013 suitable for chemotherapy treatments. One blood sample was taken before treatment (S1) and the other one, after one cycle of chemotherapy (S2). Blood samples were analyzed by CellSearch method.
Probability of survival was calculated following the Kaplan-Meier method; differences in survival were examined by the Long-Rank test.
Result
Median OS and PFS were 10 months and 6 months respectively.
OS was 6 months in patients with isolation of CTC in S1 vs 11 months in those with no isolation of CTC; no statistical differences (p=0.978).
OS was longer in those patients in whom there was no isolation of CTC in S2 compared to those in whom CTC were isolated (19 months vs 5 months; p=0.006). Contrary to this, no difference was observed considering PFS with a median of 6.5 months in patients without CTCs in their S2 and 6 months with CTCs present.
Conclusion
In our study, patients with CTC´s isolation in S2 had a worse prognostic, median of 14 months OS, compared to those in whom there were no CTC isolation.
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P2.05 - Interventional Diagnostic/Pulmonology (ID 168)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Interventional Diagnostics/Pulmonology
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.05-12 - Analysis of Biomarkers in Lung Cancer in Spain (ID 854)
10:15 - 18:15 | Author(s): Jose Luis Gonzalez Larriba
- Abstract
Background
The analysis of biomarkers in lung cancer (LC) is currently one of the most important care needs, given the importance of their presence in the selection of specific treatments. Our objective was to know the implementation degree of these tests in a large cohort of patients in Spain using the Thoracic Tumor Registry (TTR) of the Grupo Español de Cáncer de Pulmón (Spanish Lung Cancer Group).
Method
The TTR is an observational cohort multicenter study of the LC in Spain. Information on patients (p) enrolled from August 2016 to December 2018. The study is conducted according to the Declaration of Helsinki and approved by the institutional review board of each participating institute. The registry was approved by the Spanish Drug Agency as a non-post-authorization, non-interventional study.
Result
A total of 7,872 patients from 58 Spanish sites were enrolled. Analysis of molecular markers considering all the LC stages: A molecular test, the most frequent being the EGFR test, was performed in 4,456 patients (67.5%). The proportion of biomarker evaluation has varied over time, ranging from 57.9% prior to 2012 up to 73.7% in 2017.
Molecular markers in patients with stage IV. Three thousand four hundred forty-six (3,446) patients (52.2%) had a stage IV on diagnosis. The molecular assessment of some biomarkers reached 81.4% of all the patients, there being differences between Regional Communities in regard to the molecular tests made.
There was performed some biomarker test in 92% of the 2570 patients with stage IV and adenocarcinoma histology. The analysis of ALK was tested in 79% of the patients, this being in 40% only 2 years ago. ROS was studied in 20% of the cases and EGFR in 92%.
Conclusion
Although no national plan exists for molecular biomarker analysis in LC in Spain, the implementation of the biomarkers analysis in all the hospitals that contribute to the TTR is high, as close to the maximum as possible. The increase in the ALK analysis in the last period is relevant. As regional differences exist, it would be of interest to go in depth to study its cause
